Pilot Study of Biodegradable Stents for Treating High Grade Strictures in Primary Sclerosing Cholangitis

What this Trial Is About

Researchers are evaluating the use of biodegradable stents in patients with Primary Sclerosing Cholangitis PSC who have high grade strictures. The study aims to see if these stents can improve bile flow by remodeling the strictures while requiring fewer interventions compared to balloon dilation alone. This pilot study focuses on the technical success and safety of placing biodegradable stents during endoscopic retrograde cholangiopancreatography ERC. Participants will receive an Archimedes biodegradable stent inserted at the time of ERC to treat their high grade strictures. The study will monitor patients for up to 12 months to assess the recurrence-free rate of strictures, changes in symptoms using the Amsterdam cholestatic complaints score, improvements in liver function tests, and quality of life as measured by the Short Form-36 questionnaire. The trial will also track mortality, morbidity, complications, liver disease progression, and the need for liver transplantation. During the study, participants will undergo assessments at 2 weeks, 12 weeks, and 12 months after the initial stent placement. These evaluations include symptom scores, liver function tests, and quality of life measures. Researchers will also monitor for adverse events related to ERC and stent placement, stricture recurrence, development of ascites, and any liver transplant requirements. The total follow-up period for each participant is 12 months to capture both short- and longer-term outcomes.

Biodegradable Stents in Primary Sclerosing Cholangitis